Kornimate/medical-research-clean huggingface dataset:
use of mellitor sensor for continuous glucose monitoring - an ex-vivo study

Conditions: Diabetes Mellitus

Summary: most patients with diabetes mellitus have to measure their blood glucose levels quite often, in order to maintain a proper glycemic control. current methods of self-monitoring of blood glucose are invasive, painful, uncomfortable, and only allow occasional, from time-to-time, measurements. real-time continuous monitoring would provide a helpful tool for improvement of glycemic control, thus decreasing the incidence of hypoglycemia and improving glucose control. the mellitor sensor is a new concept of continue glucose monitoring device. the mellitor device is an implantable continuous glucose monitoring sensor that is intended for detection episodes of hyperglycemia and hypoglycemia in diabetic patients, and facilitates both acute and long-term therapy adjustments. this study was design in order to evaluate glucose measurement capabilities by the mellitor sensor that is being developed. transudate liquid samples, withdrawn in a clinical procedure and normally immediately disposed, will be used for glucose measurement by the mellitor sensor. study design this study is an ex-vivo comparative study. 20 patients will be recruited for the study, according to patients' inflow and meeting eligibility criteria. study goal study objective is to evaluate the feasibility of the mellitor sensor technology for glucose level measurement. study endpoint mellitor technology feasibility will be established by comparing mellitor glucose measurements results, based on transudate/exudates liquid withdrawal for other medical reasons, to "gold standard, yellow springs" glucose analyzer, or a comparable, calibrated and approved device using the same transudate/exudates liquid. interdevice variability should be within 10%.


Eligibility criteria:
inclusion criteria: * male/female aged 18 and up. * subject was scheduled for transudate/exudate liquid withdrawal. * subject able to comprehend and give informed consent for participation in this study. * signed informed consent form exclusion criteria: * known cognitive or psychiatric disorder. * subjects with hiv. * subject refuses to sign inform consent form.

Keywords: glucose measurements
effectiveness of qigong vs. physiotherapy to improve quality of life of women with fibromyalgia

Conditions: Fibromyalgia

Summary: this study analyze the effectiveness of a physiotherapy treatment versus a qigong exercise programme improving quality of life of subjects with fibromyalgia.

objective: this study investigated the effectiveness of a physiotherapy treatment versus a qigong exercise programme for the improvement of the quality of life of subjects with fibromyalgia. design: a single-blind randomized clinical controlled trial. setting: university of extremadura, spain subjects: women with fibromyalgia interventions: 141 participants were randomized to a qigong exercise program group (n=47), a physiotherapy treatment group (n=47) and control group (n=47) for 6 weeks. main measures: measures were taken at baseline (week 0), pre intervention (week 1) and post intervention (week 6). the primary outcome measure were quality of life (spanish fibromyalgia impact questionnaire (sfiq), pain (vas), perceive exertion (borg scale), spirometry measures (spirobank-g mir spirometry) and balance (wii-fit, nintendo ©). the secondary outcome measures were flexibility (wells and dillon test and sit and reach test), range of movement (goniometer), muscle strength (lowett scale).

Eligibility criteria:
inclusion criteria: * women between 30 and 65 years old, * diagnosed with fibromyalgia by a specialized physician, exclusion criteria: * the exclusion criteria were to present any limitation of mobility due to fibromyalgia or other pathology, previous practice or knowledge of qi gong, to be under physiotherapy treatment and to practice any physical exercise.

Keywords: fibromyalgia physiotherapy qigong quality of life
post market clinical follow-up study protocol for conserve® press-fit femoral components

Conditions: Joint Disease

Summary: microport orthopedics (mpo) is conducting this pmcf study to evaluate the safety and efficacy of its tha and resurfacing components marketed in the eu. these types of studies are required by regulatory authorities for all tha and resurfacing devices that do not have medium to long-term clinical evidence available at the time of gaining approval to market in the eu. this study has been designed in accordance with meddev 2.12/2 rev 2.

microport orthopedics inc. (mpo) currently markets several total hip arthroplasty (tha) and resurfacing components throughout the world, including the european union (eu). as part of the process for gaining approval to market in the eu, mpo is conducting this post market clinical follow-up (pmcf) study to evaluate the safety and efficacy of these components. the objectives of this study are to evaluate component survivorship, total functional outcome scores, and radiographic outcomes of implanted subjects at out to 10 years follow-up.

Eligibility criteria:
inclusion criteria: * has undergone primary hip resurfacing for any of the following: * non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, or painful hip dysplasia; * inflammatory degenerative joint disease such as rheumatoid arthritis; or * correction of functional deformity * subject is implanted with the specified combination of components * subject is willing and able to complete required study visits or assessments exclusion criteria: * subjects skeletally immature (less than 21 years of age) at time of primary resurfacing surgery * subjects currently enrolled in another clinical study which could affect the endpoints of this protocol * subjects unwilling to sign the informed consent document * subjects with substance abuse issues * subjects who are incarcerated or have pending incarceration

Keywords: osteoarthritis avascular necrosis ankylosis protrusio acetabuli painful hip dysplasia rheumatoid arthritis correction of functional deformity revision procedures
effect of 10 minute-prewarming on core body temperature during gynecologic laparoscopic surgery under general anesthesia

Conditions: Hypothermia; Anesthesia

Summary: previous research has shown beneficial effects of prewarming on preventing inadvertent perioperative hypothermia (iph). warming the surface of the body before the induction of anesthesia can reduce the temperature difference between the core and periphery, thereby reducing the degree of core-to-peripheral thermal redistribution. it has been proved that initiation of warming before surgery can be more useful for preventing iph than warming only during surgery. nevertheless, there are not many researches on effects of short period (\<30 min) prewarming, especially in gynecologic laparoscopic surgery. accordingly, the investigators designed this study to test if iph can be effectively prevented when 10 minutes of prewarming is added to intraoperative active warming in patients undergoing gynecologic laparoscopic surgery.


Eligibility criteria:
inclusion criteria: * asa physical status 1 or 2 patients * patients who underwent gynecologic laparoscopic surgery under general anesthesia exclusion criteria: * preexisting hypothermia (\ 37.5℃) * anesthesia last for \ 2 hours * conversion from laparoscopic surgery to laparotomy * patients with a body mass index (bmi) ≥ 31kg/m2 * patients with known thyroid disease

Keywords: perioperative hypothermia core body temperature prewarming gynecologic laparoscopic surgery
post-approval study of the glaukos® istent® trabecular micro-bypass stent: extended follow-up of the premarket cohort

Conditions: Primary Open Angle Glaucoma

Summary: the purpose of this study is to assess the long-term safety of the glaukos® istent® trabecular micro-bypass stent model gts100r/l in subjects previously enrolled in glaukos study gc-003.

the goal of this study was to demonstrate that use of this device in conjunction with cataract surgery did not result in a rate of sight-threatening adverse events, after 5 years of implantation that was higher than the rate of sight-threatening adverse events that occurred after cataract surgery alone, by more than a non-inferiority margin of 5%.

Eligibility criteria:
inclusion criteria: * subjects previously enrolled in glaukos study gc-003 who are able and willing to participate in this extended follow-up study exclusion criteria: * subjects previously enrolled in glaukos study gc-003 who are not able or willing to participate in this extended follow-up study * patients not previously enrolled in glaukos study gc-003

Keywords: primary open-angle glaucoma (poag) trabecular meshwork istent
phase 1a/1b first-in-human study of bg-c9074 alone and in combination with tislelizumab in participants with advanced solid tumors

Conditions: Advanced Solid Tumor

Summary: this is a first-in-human, dose finding and dose expansion study to evaluate the safety, tolerability, pharmacokinetics (pk), pharmacodynamics, and preliminary antitumor activity of bg-c9074 alone and in combination with tislelizumab in participants with advanced solid tumors.


Eligibility criteria:
inclusion criteria: 1. able to provide a signed and dated written informed consent prior to any study-specific procedures, sampling, or data collection. 2. eastern cooperative oncology group (ecog) performance status ≤ 1. 3. participants with selected histologically or cytologically confirmed advanced, metastatic, and unresectable solid tumors who have been previously treated. 4. ≥ 1 measurable lesion per response evaluation criteria in solid tumors, version 1.1 (recist v1.1) 5. able to provide an archived tumor tissue sample. 6. adequate bone marrow and organ function. 7. females of childbearing potential must be willing to use a highly effective method of birth control for the duration of the study, and for ≥ 7 months after the last dose of study drug(s). 8. nonsterile males must be willing to use a highly effective method of birth control for the duration of the study treatment period and for ≥ 4 months after the last dose of study drug(s). exclusion criteria: 1. prior treatment with a b7 homolog 4 (b7h4)-targeting antibody-drug conjugate (adc) or an adc with a topoisomerase 1 inhibitor (top1i) payload. 2. active leptomeningeal disease or uncontrolled, untreated brain metastasis 3. any malignancy ≤ 2 years before the first dose of study treatment(s) except for the specific cancer under investigation in this study and any locally recurring cancer that has been treated with curative intent (eg, resected basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix or breast). 4. history of interstitial lung disease, ≥ grade 2 noninfectious pneumonitis, oxygen saturation at rest \< 92%, or requirement for supplemental oxygen (including intermittent use) at baseline. 5. uncontrolled diabetes. 6. infection (including tuberculosis infection) requiring systemic (oral or intravenous) antibacterial, antifungal, or antiviral therapy ≤ 14 days before the first dose of study treatment(s). note: other protocol defined inclusion/exclusion criteria may apply.

Keywords: bg-c9074 tislelizumab advanced solid tumors first-in-human b7h4
bone marker assessment of multiple myeloma patients treated with aminobisphosphonates

Conditions: Multiple Myeloma

Summary: the purpose of this research study is to define the time a molecule in the participants bones called ntx begins to rise after receiving treatment with bisphosphonates. ntx is measured in the urine to determine the rate of bone breakdown. tracking this marker may help identify a more optimal dosing schedule of bisphosphonate therapy. bisphosphonate drugs like zoledronic acid, which will be used in this study, are used to reduce pain and bone fractures in people with multiple myeloma. there is some laboratory data to suggest that they may work against myeloma. participants will have already undergone bisphosphonate therapy and may have received zoledronic acid as treatment. typically these agents are continued indefinitely. due to concerns of their long-term side effects we are looking at alternate strategies for reducing the frequency of these agents.

* each participant will receive a single dose of zoledronic acid intravenously after the screening procedures. * participants will then return to the clinic once every month for 6 months and have the following tests and procedures performed: medical history update; physical exam; ecog (eastern cooperative oncology group) performance status; blood tests; and urine tests. * after 6 months there will be an end of study visit, where the following procedures will take place: medical history update; bone marrow aspirate and biopsy; skeletal survey.

Eligibility criteria:
inclusion criteria: * men or women 18 years of age or older * confirmed diagnosis of multiple myeloma(mm) by durie and dalmon staging criteria on iv bisphosphonate therapy with either pamidronate or zoledronic acid for 8-12 months * mm patients in either cr (complete response) or pr (partial response) by ebmt criteria * ecog performance status of 0-2 exclusion criteria: * mm patients on active anti-mm therapy (maintenance regimens allowed) * renal failure with serum creatinine \>2mg/dl and/or creatinine clearance of \<30ml/min * relapsed, refractory or progressive disease * any condition or situation that, in the opinion of the investigator, may put the subject at significant risk, confound the results of the study, or interfere significantly with the subject's participation in the study * hypersensitivity or any contraindication to a single dose of zoledronic acid

Keywords: aminobisphosphonates
prevalence of coronary artery disease in the siblings of premature coronary heart disease

Conditions: Coronary Heart Disease

Summary: the aim of this prospective study is to investigate the prevalence of coronary artery disease using computed tomography with family history of premature coronary heart disease


Eligibility criteria:
inclusion criteria: * within 1 year * the siblings of premature coronary heart disease (male\<55years old, female\<65yeasrs old: framingham heart study) patients admitted relevant hospital exclusion criteria: * documented coronary heart disease * experienced adverse events with relevant treatment * contraindicated with beta-blockers * any woman of childbearing potential who is pregnant, seeking to become pregnant or suspects

Keywords: coronary heart disease computed tomography prevalence of coronary artery disease
study to evaluate blood and urine kidney injury markers to facilitate early detection of renal adverse drug events in pediatric cancer patients treated with nephrotoxic chemotherapy

Conditions: Kidney Impairment

Summary: this study is to investigate blood and urine kidney injury markers (especially uromodulin) in pediatric cancer patients treated with nephrotoxic chemotherapy. uromodulin is a marker to detect and monitor tubular injury and renal function.


Eligibility criteria:
inclusion criteria: * signed informed consent by their-selves (≥ 14 years) or their legal representatives (\< 14 years or in case of lacking capacity of judgement) * cancer diagnosis, that indicates a nephrotoxic chemotherapy including the drugs high dose mtx (hd-mtx), ifosfamide, cis- and carboplatin. exclusion criteria: * critically-ill patients with inotropic and/or vasopressor drugs * signs of severe sepsis * receiving other nephrotoxic drugs parallel to the chemotherapy cycle

Keywords: nephrotoxic chemotherapy pediatric cancer patients renal adverse drug events renal function renal tubular injury uromodulin drug related kidney injury kidney markers
china collaborative study on epidemiology of acute kidney injury

Conditions: Acute Kidney Injury

Summary: acute kidney injury (aki) is a common clinical syndrome, especially patients in the hospital. aki has become a huge medical burden in china. little information is available about this disease burden in our country. the investigators aimed to evaluate the burden of aki and to analyze the related risk factors.

the investigators launch a nationwide of all patients, who were admitted to hospital from 2011-2016. patients were diagnosed on the basis of changes in serum creatinine by the laboratory information system. the investigators assessed rates of aki according to the criteria of 2012 kidney disease improving global outcomes (kdigo).

Eligibility criteria:
inclusion criteria: * the patients diagnosed on the basis of changes in serum creatinine according to the criteria of 2012 kidney disease improving global outcomes(kdigo) exclusion criteria: * serum creatinine record less than two times during hospitalization * patients being diagnosed with end-stage kidney disease (chronic kidney disease stage 5) * nephrectomy * kidney transplantation * peak serum creatinine of less than 53µ mol/l * serum creatinine decrease after amputation
a study of the combination of electrical stimulation and dysport® in myofascial pain syndrome.

Conditions: Myofascial Pain Syndromes

Summary: the purpose of this study is to determine whether electrical stimulation enhances the effect of botulinum toxin type a (dysport®) on myofascial pain syndrome.


Eligibility criteria:
inclusion criteria: * chronic neck and shoulder pain for at least 6 months, refractory with other conservative treatments * presents at baseline with pain score greater than 50mm on 100mm length vas. pain score will be measured as overall pain over the 7 days preceding the visit during activities * active trigger point (trp) defined as a tender spot localised in a taut band of muscle fibres associated with tenderness and referred pain recognised by the patient into well-defined areas that are remote from the trp area at palpation and preferably local twitch response at palpation and/or jump sign at palpation exclusion criteria: * disc/bone disease * history of surgery on neck * neurological deficits, neuromuscular junction disorder, motor neuron disease * patient has received anesthetic injections to the target trigger point within 4 weeks of study enrolment, or corticosteroid injections within 3 months * systemic inflammatory disease * hypersensitivity to dysport® * diffuse tender points, or diagnosed with fibromyalgia * previous electrical stimulation * previous injection of dysport® within 6 months of study enrolment
ultrasonographic evaluation of the effect of occlusal splint treatment on masseter muscle thickness in children with sleep bruxism:a clinical pilot study

Conditions: Bruxism, Sleep

Summary: the aim of this study was to evaluate the effectiveness of occlusal splint in pediatric bruxist patients by ultrasonic measurements of masseter muscle thickness and pain perception.

the aim of this study was to evaluate the effectiveness of occlusal splint by ultrasonographic measurements of masseter muscle thickness and pain perception in a group of pediatric bruxist patients. the study included patients aged 7 to 12 years, all in the mixed dentition period, with class i occlusion and diagnosed with probable bruxism. a 2 mm thick soft occlusal splint was prepared for each patient. ultrasonic measurements were used to assess the thickness of the masseter muscle (mmt) at baseline, one, two and three months.visual analog scale (vas) was also used to record subjective pain measurements. repeated-measures anova and friedman test were used in the statistical analysis

Eligibility criteria:
inclusion criteria: * symptoms of tooth clenching or grinding when sleeping at night or during the day, including headaches in the morning, as reported by parents during anamnesis. * attrition-type tooth wear, as well as discomfort, fatigue, and/or pain in the jaw muscles when palpated during a clinical examination. the clinical diagnosis of attrition was based on the following findings: * shiny and flat facets. * the enamel and dentin wear at the same pace. * wear patterns on opposing teeth's occlusal surfaces. * possible breakage of cusps or restorations. * impressions on the cheeks, tongue, or lips. exclusion criteria: * children with any chronic/systemic/psychological disease, presence of tmd symptoms, lack of posterior teeth that may cause unilateral chewing, use of any medication that may affect muscle activity, dental malocclusions (any skeletal jaw problems in anteroposterior and vertical dimensions) and ongoing orthodontic treatment

Keywords: bruxism child usg masseter muscle occlusal splint
corchorus olitorius buccal films for the treatment of recurrent minor aphthous ulcerations

Conditions: Aphthous Ulcer Recurrent

Summary: a methanol extract of corchorus olitorius edible plant was perpared for extration of glycosideal compounds. the extract was tested for its efficacy as antiinflammatory and analgesic activity invitro and approved by the biomarkers. a fast dissolvinf mucoadhesive film was prepared by a certain amounts of highly safe polymers for a pilote study on human for treament of aphthous ulcerations. two groups of study, placebo and intrvention will be recurited and followed for pain, erthymia and size of ulcers for 6 days.


Eligibility criteria:
inclusion criteria: 1. males and females aged 18-65 years old 2. willingness to participate and sign the informed consent forms 3. presenting with 1 to 5 aphthous ulcers (less than 72 hours' duration) with a size no greater than 5 mm in diameter 4. an expectation that their ulcers normally take 5 or more days to resolve without treatment exclusion criteria: * a known history of serious drug hypersensitivities 2. pregnancy and lactation (urine hcg-positive) 3. concurrent clinical conditions that could pose a health risk to the subjects, including serious liver, kidney, and heart dysfunctions 4. a history of an immunologic problem
efficacy and safety of substitution of glucocorticoid for bdb-001 injection in patients with anti-neutrophil cytoplasmic antibody(anca)-associated vasculitis

Conditions: ANCA-associated Vasculitis

Summary: the aim of the trial is to study the efficacy and safety of treatment with bdb-001 injection substitution of glucocorticoid in patients with anca-associated vasculitis.


Eligibility criteria:
inclusion criteria: * 18 years old≤age≤75 years old, male or female; * diagnosis of granulomatosis with polyangiitis(gpa) or microscopic polyangiitis(mpa)； * newly diagnosed or relapsed gpa or mpa that requires treatment with cyclophosphamide(cyc) and glucocorticoids(gcs)； * positive test for anti-proteinase 3(pr3) or anti-myeloperoxidase (mpo)； * estimated glomerular filtration rate ≥15 ml/minute/1.73 m\^2； * at least 1 major item, or at least 3 non-major items, or at least the 2 renal items on bvas； exclusion criteria: * active tuberculosis infection; * severe disease as determined by rapidly progressive glomerulonephritis, alveolar hemorrhage requiring pulmonary ventilation support, rapid-onset mononeuritis multiplex or central nervous system involvement； * any other known multi-system autoimmune disease including eosinophilic granulomatosis with polyangiitis (churg-strauss), systemic lupus erythematosus, iga vasculitis (henoch-schönlein), rheumatoid vasculitis,anti-glomerular basement membrane disease, or cryoglobulinemic vasculitis； * hbsag positive,or hbcab positive and hbv-dna positive； * received cyc within 3 months before the first administration or received rituximab(rtx) within 12 months before the first administration； * received glucocorticoid shock therapy within 4 weeks before the first administration； * received an oral daily dose of a gc of \> 10 mg prednisone-equivalent for more than 6 weeks continuously before the first administration； * received a anti-tumor necrosis factor and other biological agents treatment within 12 weeks before the first administration； * received continuous dialysis treatment for 12 weeks or more before the first administration; received dialysis within 1 week before the first administration; * received intravenous immunoglobulin (ig) or plasma exchange within 4 weeks before the first administration; * pregnant or lactating.